SKIN CRAVE BROAD SPECTRUM SPF30- spf30 broad spectrum sunscreen lotion lotion 
Tropical Enterprises International Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Spf 30 Broad Spectrum Sunscreen - water based

Directions: Apply liberally and evenly 15 minutes before sun exposure.

Reapply every 2 hours as needed, after 40 minutes of swimming or sweating, or immediately after towel drying.

Inactive Ingredients:

Water, Polyester-7, Neopentyl Glycol Diheptanoate, Triethanolamine, Hypromellose, Acrylic Polymer, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium EDTA

Uses: Helps prevent sunburn. If used as direted with other sun protection measures, decreases the risk of skin cancer and eraly aging caused by the sun.

Keep out of reach of children. If product is swallowed, seek immediate medical attention or contact a Poison Control Center right away.

Purpose: Sunscreen

WARNINGS:

For external use only.

When using this product avoid contact with eyes. If contact with eyes occurs, flush with water to remove.

Stop use and ask a doctor if irritation or rash develops and persists.

Keep out of reach of children. If products is swalled, seek immediate medical attention or contact a Poison Control Center right away.

Active Ingredients:

Octocrylene 10%

Homosalate 10%

Oxybenzone 6%

Octisalate 5%

Avobenzone 3%

PLPDP

SKIN CRAVE BROAD SPECTRUM SPF30 
spf30 broad spectrum sunscreen lotion lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-224
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYESTER-7 (UNII: 0841698D2F)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58418-224-1010 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2012
2NDC:58418-224-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2012
3NDC:58418-224-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2012
4NDC:58418-224-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2012
5NDC:58418-224-12360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
6NDC:58418-224-641920 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
7NDC:58418-224-283840 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
8NDC:58418-224-08240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2012
Labeler - Tropical Enterprises International Inc (091986179)
Registrant - Tropical Enterprises International Inc (091986179)

Revised: 12/2014
Document Id: 097c571a-e7be-0e01-e054-00144ff8d46c
Set id: 097c571a-e7bd-0e01-e054-00144ff8d46c
Version: 1
Effective Time: 20141205
 
Tropical Enterprises International Inc